SOMERSET, N.J. - The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously endorsed CARVYKTI (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma, based on data from the Phase 3 CARTITUDE-4 study.
Legend Biotech Corporation (NASDAQ: LEGN), a biotech company specializing in cell therapy, announced the ODAC's 11-0 vote in favor of the therapy for patients who have previously undergone at least one line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
The committee's recommendation is a critical step towards FDA approval, with a target Prescription Drug User Fee Act (PDUFA) date set for April 5, 2024. The positive vote reflects the committee's assessment of the risk-benefit profile of cilta-cel, which was found favorable for the proposed indication.
CARVYKTI is a genetically modified autologous T cell immunotherapy that targets B-cell maturation antigen (BCMA) and is currently indicated for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy. The CARTITUDE-4 study compared the efficacy and safety of CARVYKTI against existing treatments like pomalidomide, bortezomib and dexamethasone, or daratumumab, pomalidomide and dexamethasone.
The ODAC's role is to provide non-binding recommendations to the FDA based on its evaluation of safety and efficacy data for oncologic drug products. The final decision on drug approval is made by the FDA.
CARVYKTI has previously received approval by the FDA in February 2022 and by the European Commission in May 2022 for similar indications. It also holds Breakthrough Therapy Designation in the U.S. and China, a PRIority MEdicines designation in Europe, and Orphan Drug Designation in the U.S., Europe, and Japan.
This development is significant for patients with multiple myeloma, a blood cancer characterized by the excessive proliferation of plasma cells, with over 35,000 new cases expected to be diagnosed in 2024 in the U.S. alone. The advisory committee's support is based on the press release statement from Legend Biotech Corporation.
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